Probiotic may not help colic

NEW YORK (Reuters Health) - In a large Australian trial of a
popular type of "friendly bacteria," colicky babies given the
probiotic product cried or fussed more than babies who were
given placebo drops.

Despite smaller studies in the past suggesting that
Lactobacillus reuteri might ease babies' colic, the authors of
the new research say the new findings don't support use of the
probiotic for that purpose.

"Probiotics should not be routinely recommended for all
infants with colic because they are not effective for
formula-fed babies with colic, and their effectiveness for
breastfed babies with colic is uncertain," Dr. Valerie Sung told
Reuters Health in an email.

Sung is a pediatrician and researcher with the Murdoch
Children's Research Institute and Royal Children's Hospital in
Melbourne.

There are currently no effective treatments for infants'
colic, which is usually defined as fussing and crying for more
than three hours a day. The exact cause of the problem remains
uncertain, but it normally stops on its own by the time the baby
is three to four months old.

Colic affects about one in five babies under the age of
three months. Colicky babies are at a greater risk of shaken
baby syndrome, and their mothers are more likely to be depressed
and to stop breast-feeding early, according to past research

Previous studies have also found that babies with colic tend
to have an imbalance of "good" verses "bad" bacteria in their
guts, which can cause excess gas, bloating and pain.

Because some probiotics have been shown to provide health
benefits and to restore a bacterial balance in the digestive
tract, researchers have hoped that they might help reduce colic.

So far, results have been mixed (see Reuters Health article
of October 8, 2013, here: http://reut.rs/1mZUxDJ).

"We decided to do this study after two published Italian
studies showed L. reuteri to be effective in breastfed infants
with colic whose mothers were on dairy-exclusion diets," Sung
said.

"We recognized these studies' limitations and therefore set
up a more rigorous trial aiming to find out whether L. reuteri
would benefit both breast- and formula-fed infants regardless of
their mothers' diets," she added.

The findings were published in the British Medical Journal.

For the study, Sung and her colleagues enrolled 167 healthy
- but colicky - babies who were under 13 weeks of age. Most were
recruited from the Royal Children's Hospital emergency
department in Melbourne.

Parents gave the babies one daily dose of 6 drops of L.
reuteri or a placebo for one month and were told to keep track
for six months of the amount of time the babies spent crying or
fussing, and of how much they slept.

The researchers found that the babies in both the treatment
and placebo groups had similar results throughout the trial,
except that colic symptoms declined even more in the placebo
group during the first month than in babies getting the
probiotic.

At the end of the first month, the babies who received the
probiotic cried or fussed about 49 minutes more and slept about
47 minutes less per day than the babies in the placebo group.
The difference was seen only among formula-fed infants, however,
not among those who were breast-fed.

The researchers also collected stool samples after one month
and found that the number and types of bacteria present in the
babies' digestive tracts were about the same for those on
probiotics and those getting placebo drops.

In addition, both groups had similar levels of calprotectin,
a sign of inflammation. The exceptions were babies whose crying
or fussing had dropped by 50 percent or more - they also had
lower levels of calprotectin.

Sung said she and her colleagues were surprised by the
results since the three smaller previous trials using the same
probiotic at the same dose showed it to be beneficial.

Roger Clemens, who was not involved in the research, told
Reuters Health that one possible problem with studies on colicky
babies might be a poor understanding of what is normal, healthy
flora of the digestive tract in babies.

'What we find is missing in all the papers - and there have
been a lot of papers on this topic on probiotics and colicky
babies - is that we don't know what that baseline is," said
Clemens, a researcher and associate director of the regulatory
science program at the University of Southern California School
of Pharmacy in Los Angeles.

He said that even without that baseline information, this
study is important because it's part of the pool of information
that needs to be collected.

"Bottom line is, I'm not pessimistic with the study - I
think it's a very important study that really needed to be
done," he said. "I just think it just needs to be taken to the
next step."

Sung said she and her colleagues are in the process of
collaborating with other similar studies around the world to
pool data for a larger analysis.

In the meantime, Sung advises parents to seek medical advice
and gather as much practical support as they can at home to help
them get through a very difficult phase, and to know that their
baby's crying will improve over time.